Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04109066
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — BIOLOGICAL
    Specified Dose on Specified days
  • paclitaxel (PTX) — DRUG
    Specified dose on Specified days
  • nivolumab placebo — OTHER
    Specified dose on Specified days
  • anthracycline — DRUG
    Specified dose on Specified days
  • cyclophosphamide — DRUG
    Specified dose on Specified days
  • Endocrine Therapy — DRUG
    Variable endocrine therapy of investigators choice
  • Surgery — PROCEDURE
    Surgery for breast cancer

Study Details

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

Key Dates

Start date
Nov 18, 2019
Status verified
Dec 2024
Primary completion
Jan 16, 2023
Completion
Dec 27, 2023

Study Design

Enrollment
521 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
    Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice
  • Placebo Comparator: Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET
    Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: Up to approximately 37 months ]

Locations (30)

FacilityCityStateZIPSite coordinators
Local Institution - 0136MobileAlabama36604-
Local Institution - 0052GreenbraeCalifornia94904-
Local Institution - 0051WhittierCalifornia90603-
Local Institution - 0182StamfordConnecticut06904-
Local Institution - 0150JacksonvilleFlorida32256-
Local Institution - 0097MiamiFlorida33136-
Local Institution - 0149PensacolaFlorida32504-
Local Institution - 0120TallahasseeFlorida32308-
Local Institution - 0054AthensGeorgia30607-
Local Institution - 0107AtlantaGeorgia30342-
Local Institution - 0056ColumbusGeorgia31904-
Local Institution - 0221ChicagoIllinois60611-
Local Institution - 0227Fort WayneIndiana46804-
Local Institution - 0222TopshamMaine04086-
Local Institution - 0146BethesdaMaryland20817-
HCA Midwest DivisionKansas CityMissouri64132-
Local Institution - 0109Florham ParkNew Jersey07932-
Local Institution - 0050HackensackNew Jersey07601-
Local Institution - 0180New BrunswickNew Jersey08903-
Local Institution - 0181AlbuquerqueNew Mexico87131-
Local Institution - 0041The BronxNew York10461-
Local Institution - 0283CharlotteNorth Carolina28204-
Duke Cancer InstituteDurhamNorth Carolina27710-
Local Institution - 0053ClevelandOhio44109-
Local Institution - 0218NashvilleTennessee37203-
Local Institution - 0121Fort WorthTexas76104-
Local Institution - 0224FairfaxVirginia22031-
Local Institution - 0122FredericksburgVirginia22408-
Virginia Cancer InstituteRichmondVirginia23230-
Local Institution - 0274SeattleWashington98109-

Find similar trials in Mobile, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Local Institution - 0136· Mobile, ALLocal Institution - 0052· Greenbrae, CALocal Institution - 0051· Whittier, CALocal Institution - 0182· Stamford, CTLocal Institution - 0150· Jacksonville, FLLocal Institution - 0097· Miami, FL

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